Review finds data on antidepressants biased and misleading

Many individuals who work in healthcare, and perhaps quite a few who don’t, will have noticed a general thrust in the direction of what is known as ‘evidence-based medicine’. I have serious reservations about evidence-based medicine, myself. For a start, although evidence-based practice was originally billed as: ‘The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research,’ [1] it’s amazing to me just how often that first bit is forgotten. Having said that, the individuals who forget the importance of clinical experience do often seem to be academics who don’t see patients. I suppose it’s only natural if you don’t have much clinical experience then you’re not going to give that much credence to it.

And even if we focus on the science and the studies, evidence-based medicine is still fraught with difficulty. And just one factor here is what is known as ‘publication bias’ ” which describes the phenomenon when ‘positive’ studies tend to be more readily published than ‘negative’ ones. Such shenanigans are well known in medical research, and can give a very skewed impression of drug effectiveness and its risk-benefit profile.

This week’s New England Journal of Medicine carried an interesting article which sought to identify publication bias in the area of antidepressant medication [2]. The researchers assessed a total of 74 studies that had been registered with the FDA (Food and Drug Administration) in the USA. Some of these studies had been published, but many (details below). The researchers obtained the unpublished studies via various means including the invoking of the freedom of information act.

Analysing the 74 studies, the researchers found that:

38 had positive results, and all but one of these had been published.

36 had negative results, and 22 of these had not been published at all.

Of the 36 negative studies, 11 had been published, but in a way that conveyed a positive outcome (this is not ‘publication bias’ by the way, just plain ‘bias’).

This meant that of all the published studies, 94 per cent appeared to have positive findings.

However, FDA analysis revealed that 51 per cent of studies were genuinely positive.

Overall, publication bias meant that the drugs appeared about a third more effective than they are in reality (if all trials are taken into consideration).

The lead author of this study, Dr Erick Turner, is reported as saying: The bottom line for people considering an antidepressant, I think, is that they should be more circumspect about taking it.� That sounds like good advice to me. But I’d add that this data also suggests that doctors might be a bit more circumspect about prescribing them in the first place.

This is not the first time that there’s been evidence of publication bias in the area of antidepressants. Previous analysis found the same situation seems to have gone on regarding the use of antidepressants in adolescents [3]. This Lancet review found that while published studies support the use of a variety of various antidepressants in childhood depression, unpublished data shows that, in the main, risks of treatment such as an enhanced tendency towards suicidal behaviour seem to have been significantly underplayed. All this stuff on selective publication of data on antidepressant medication makes pretty depressing reading, I reckon.

References:

1. Sackett DL, et al. Evidence based medicine: what it is and what it isn’t: It’s about integrating individual clinical expertise and the best external evidence. BMJ 1996;312(7023):71-72.

2. Turner EH, et al. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med. 2008;358(3):252-60.

3. Whittington CJ, et al. Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data. Lancet. 2004;363(9418):1341-5

6 Responses to Review finds data on antidepressants biased and misleading

  1. Janet Alton MNIMH 25 January 2008 at 10:59 am #

    Antidepressants do help some people but by no means all. For some people their mood is unchanged – which simply prompts the GP to raise the dose (to no effect) – and others experience such unpleasant side-effects that they are unwilling to take the drugs. This whole issue of side-effects with prescription drugs – which is huge – is routinely ignored. You make a good point when you say that the academics conducting trials are not usually the people who see patients. We have become so persuaded that our personal experience is too subjective to be of any value that it is now routinely derided and ignored. So when the patient complains to the doctor about side-effects, or lack of efficacy of the drug, the doctor thinks, “well, the statistics show that this drug works”. Then the patient is made to feel that they are somehow at fault, because “it can’t possibly be the drug” that is making them feel ill! The saddest thing is that the drug companies now have such a stranglehold over the BMA (because of their so-called “gold standard” research) that most doctors find it impossible to believe that other therapies may work better for individual patients – herbalism, nutrition, EFT, acupuncture, etc. – therapies which may not have the backing of expensive clinical trials – and therefore do not suggest them.

  2. Matty Maccaro 25 January 2008 at 3:06 pm #

    What no one wishes to look at is the undeniable relief from serious depression that can be attained by using Omega 3 fish oils to support proper brain function and complementing this with the entirely safe 5 HTP (L-5 hydroxtryptophan) which is a precursor to serotonin.
    I am not a doctor, but I am not a fool, after many years of riding a merry-go-round of one antidepressant drug after another combined with untold DIRECT effects (they say side effects) of strong antidepressant drugs, the quality of my life had NOT improved, if the depression subsided, anxiety would soar and I often wondered if the “cure” was not worse than depression itself. Against all doctors orders, I very gradually (6 months) weaned myself off antidepressants and started out with 6 grams of Omega 3 fish oils a day and 200mg of 5HTP. Depression free within months, I decreased the fish oils.
    Doctors told me I needed to take antidepressants for the rest of my life. Isn’t that precisely what the pharmaceutical companies want the doctors to tell patients? I am now beginning my 9th year without depression. Another major point is that exercise and helping others is a great antidote to depression. Finally, I am amazed at the unneccessary suffering people are willing to endure, the excuses patients and their families will make, such as “how can I exercise? I’m too depressed” and the blind faith folks invest in doctors who write the prescriptions & refer you to “therapists” who rehash the past ad infinatum. Surely Big Pharma has succeeded in getting tens of millions to think they could not live a day without these antidepressant drugs. Any time I have told my experience to others, usually who either suffer depression or have a family member who suffers, they look at me oddly or say something like “…doesn’t fish oil taste bad or make you burp?” they are terrified to even think of getting these antidepressants out of their bodies, yet continue to hate the zombie like lives they live. Let’s have a study of drug company propaganda and its astounding effectiveness.
    Thanks, Dr. Briffa for allowing this forum!

  3. Annabelle Hogan 27 January 2008 at 10:17 am #

    The blog and comments above are very interesting and it is a topic that is very relevant to me at the moment. I have had problems with anxiety on and off for a number of years. Generally, as a rule, I have managed it ok without drugs (I have occasionally been prescribed diazapam which I have take very rarely).

    I am fully functioning, in a great relationship, just completed my masters and holding down a good job, however I did have a flare up of the anxiety over the Xmas period (probably along with half the UK population!). I visited my Dr for a referral to a CBT therapist to help me manage my anxious thoughts as a short dose of therapy has helped me in the past. After explaining my wishes to my Dr (a reasonably modern young GP), and after taking a very brief history, she quickly recommended antidepressants, stating there was now ‘considerable evidence’ over the past 5 years to suggest antidepressants were effective for general anxiety disorders. She did not asking how I was currently managing the anxiety, nor if I was taking any form of exercise. I reluctantly agreed, however came away from the appointment feeling quite disillusioned. I was quite clear that on a day to day basis, I was coping ok and that my last ‘flare up’ was 3 years ago, which in my eyes is a fairly good indication that, perhaps with a little therapy, I would overcome this ‘hiccup’ also. Why would I need to take daily medication for something that I occasionally have? Needless to say, I didn’t buy nor take the antidepressants and will wait until see a therapist to help me decide if this is the best course of action. To be honest, I hope it is not, because I worry (or course!) about the potentially horrible side effects.

    What I find difficult also is now I am no longer studying, I do not have access to all the journals I once did, therefore I cannot read and judge the ‘considerable evidence’ for the use of antidepressants for generalised anxiety disorders for myself. Perhaps these were some of the published ‘pro-antidepressant’ articles that John was discussing in his blog?

    Annabelle

  4. helen 28 January 2008 at 10:10 pm #

    I sometimes wonder if people in general including doctors don’t just go for the quick fix drug option when life gets a little too hard to cope with.
    Honestly the pace things move at now the rapid changes in ideas across the board not just in technology but in all areas of life are happening at a much faster rate now than ever before. It is little wonder that people need to take a deep breath & relax a bit. Is it any wonder people think they have depression or anxiety about things & generally can’t cope with life, when even the mourning period for death of a loved one has dropped from an acceptable year or two as in past generations to get over it & move on with your life put out there by the “happiness” gurus telling us we need to move on, or take a pill to “fix” us.
    I often wonder what people mean when they say they just aren’t ‘happy’. Why are we in pursuit of this “happiness” state as a constant thing in our lives anyway? isn’t this just as harmful as a constant “unhappiness” state? People are being programmed into thinking that they aren’t good enough, their lives aren’t good enough & they can never be too happy all in my opionion so that the drug companies can make money selling “happy” pills to a population that thinks they need them so that they suddenly become good enough!
    I’m not saying that some people don’t need chemical help to achieve a “normal” state for short periods of their lives (there’s another one of those words that actually means nothing or all things like “moderation” – I mean who’s idea of normal, moderation, happy or good enough are we trying to live up to anyway?) but the growth in the use of these “happy pills” is growing way out of hand & unless there is a real chance of harm to self or others then maybe they shouldn’t be prescribed at all! And other methods of therapy work just as well they are only a little bit slower.
    People worry about the “drug culture” out there in the streets but never seem to worry about the drug culture out there in doctor prescription land. Same drugs different method of getting them really.
    Many illnesses physical & mental are in all probability caused by nutrient deficencies & in my opinion too much sugar in all its forms in the diet. But instead of treating the whole person including finding out what is going on in their lives or not often the first port of call in the drugs, really this should be the last option.

  5. Miss Sylvia Wainhouse 18 February 2008 at 11:33 am #

    Unfortunately, these comments are somewhat belated and I haven’t read all of the above, however I do have something useful to add.

    Above all, a healthy diet is paramount. In addition, vitamin B3 in the form of niacinamide, along with a B complex supplement, and an amino acid complex (free-form), taken in the appropriate way, i.e. with fruit juice, on an empty stomach, away from anything containing protein. Extra DLPA or L-Tyrosine may also prove beneficial.

    I have suffered from depression and I was put on three lots of medication by the doctor, with no explanation, the affects of which were pretty drastic; one dose of one of them and I could sleep for England…all night and all of the next day. I had to force myself to overcome the effects, with great difficulty. (With hindsight, magnesium – the anti-stress mineral – for emotional health, would have probably served me better.)

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